AVID Medical, Inc.: Device Recall
Recall #Z-0927-2026 · 11/14/2025
Class II: Risk
Recall Details
- Recall Number
- Z-0927-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- AVID Medical, Inc.
- Status
- Ongoing
- Date Initiated
- 11/14/2025
- Location
- Toano, VA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 240 units
Reason for Recall
Potential for incomplete seal on header bag.
Product Description
Halyard, EP LAB PK. Catalog Number: ESJH009-03.
Distribution Pattern
US distribution to GA, IL, NE, MD.
Other Recalls by AVID Medical, Inc.
- Class II: Risk 11/14/2025
- Class II: Risk 11/14/2025
- Class II: Risk 11/14/2025
- Class II: Risk 11/14/2025
- Class I: Dangerous 11/11/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.